Device to Assist With Abdominal Access During Laparoscopic Surgery

Stanford University

Status: Completed

Conditions: Laparoscopic Surgery

Treatments: Device: TauTona Pneumoperitoneum Assist Device (TPAD); Procedure: Standard of Care (SOC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04392635

IRB-55013

Details and patient eligibility

About

The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >/= 18
• Scheduled for laparoscopic surgery
• Able to understand and willing to sign a written informed consent form

Exclusion criteria

• Age < 18
• Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.
• Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.
• Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.
• Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

TauTona Pneumoperitoneum Assist Device (TPAD)

Experimental group

Description:

Participants will receive investigational TPAD device during laparoscopic surgery. The TPAD was used to aid Veress needle insertion in place of surgical tools such as clamps. The TPAD was applied to the patient prior to Veress needle entry and removed after insufflation was completed.

Treatment:

Device: TauTona Pneumoperitoneum Assist Device (TPAD)

Standard of Care (SOC)

Active Comparator group

Description:

Participants will receive SOC included both direct (unassisted) entry and assisted entry using clamps, if needed, to aid in Veress needle insertion. Upon confirmation that the Veress needle was in the correct location (e.g. drop test), insufflation was initiated.

Treatment:

Procedure: Standard of Care (SOC)